RSV Market Heats Up: GSK, Pfizer, and AstraZeneca Report Strong 2023 Financial Results as Over 30 Global and Domestic Companies Vie for a Share of the $10B+ Opportunity

On January 2, AstraZeneca's official website announced that Beyfortus has been approved in China and is expected to be launched during the 2024-2025 Respiratory Syncytial Virus (RSV) season.

Beyfortus's trade name in China is Lovinal, and its active ingredient is Nirsevimab, a long-acting monoclonal antibody used to prevent lower respiratory tract infections caused by RSV in infants and young children.

Nirsevimab, jointly developed by AstraZeneca and Sanofi, was approved in the EU in October 2022 and received FDA approval in July 2023.

In December 2022, the NDA registration application for AK0529, an RSV treatment drug developed by Ark Biosciences, was accepted by the NMPA and included in the priority review. This small-molecule inhibitor of the RSV fusion protein prevents the virus from entering human cells by binding to the F protein of the RSV virus.

Phase III clinical trial results show that AK0529 has a rapid onset, good compliance, and demonstrates more significant clinical benefits in infants under 6 months of age, with favorable safety and tolerability. As the world's first RSV antiviral drug to successfully complete Phase III registration clinical trials, AK0529 is expected to become a groundbreaking innovative drug and gold standard in the treatment of RSV infections in pediatric patients due to its numerous advantages.AK0529 has completed Phase III clinical trials in China and has submitted an NDA application to the NMPA, but has not yet been approved for marketing by the NMPA.

On January 22, the official website of the Chinese Drug Clinical Trial Registration and Information Disclosure Platform announced that Pfizer had launched an international multicenter (including China) Phase 2/3 clinical study. This study aims to determine whether the investigational drug sisunatovir can safely prevent adults infected with respiratory syncytial virus (RSV) from progressing to severe disease. Public information indicates that sisunatovir is a novel antiviral therapy targeting RSV. Pfizer previously acquired this product through the purchase of ReViral for up to $525 million.

Sisunatovir (PF-07923568) was originally an oral fusion inhibitor under development by ReViral, designed to block RSV replication by inhibiting the fusion of the virus with host cells mediated by the F protein. Results from a Phase 2 RSV human challenge trial conducted in healthy adult volunteers showed that sisunatovir significantly reduced viral load. Previously, this product had been granted Fast Track designation by the U.S. FDA.

Advaccine is an innovative vaccine company. Its pipeline includes potential first-in-class vaccines for diseases caused by SARS-CoV-2, respiratory syncytial virus (RSV), and hepatitis B virus (HBV). Additionally, it is developing candidate vaccines related to virus-associated tumors (in preclinical stage), as well as new antigen therapeutic vaccines and tumor-associated antigen therapeutic vaccines.

ADV110Is Aidweixin OnePaymentPotential with Novel AdjuvantsRSVProtein Subunit Candidate Vaccine，Aimed at protecting children aged 6 months to 5 years and elderly people over 65.It is worth noting that, compared withMostly Targeted atFProtein-based Vaccines in DevelopmentDifferent，ADV110Targeting the G protein of RSV。

Currently, this drugCurrently in Phase II clinical trials in Australia, it has demonstrated good safety and tolerability, and can induce high levels of antibodies in the body, showing good immunogenicity and dose-response relationship.

Advaccine expects to complete all remaining research and summary work for the Phase II clinical trial of ADV110 by 2024.

Zhuhai Trinomab Biopharmaceutical Co., Ltd. ("Trinomab") is a global, clinical-stage innovative biopharmaceutical company focused on the development of original, fully human, natural monoclonal antibody drugs.

Clover Biopharmaceuticals is a global biopharmaceutical company at the commercial stage, dedicated to saving lives and improving global health through innovative vaccines.

In December 2023, Clover Biopharmaceuticals announced,RSV PreF-Trimer Subunit Candidate Vaccine (SCB-1019)Phase I clinical trial in humans has completed the enrollment of the first batch of subjects,Officially launch the Phase I clinical trial of the RSV candidate vaccine.

This is also China's first RSVPreF vaccine to enter the clinical trial stage, and the first batch of subjects has been successfully enrolled. Clover expects to announce safety and immunogenicity results in the second half of 2024, further advancing the development progress of RSV vaccines in China.

Raimon Biotech is an international biopharmaceutical enterprise focusing on the innovation and R&D of mRNA vaccines and novel drugs. Its global headquarters is located in Maryland, USA, and its China headquarters is located on Guangzhou International Bio Island.

On December 18, 2023, the clinical trial application for RV-1770, an innovative RSV mRNA vaccine independently developed by Dami Bio, has been officially approved by the U.S. FDA. A Phase I clinical trial will soon be launched in the United States to evaluate its safety in healthy subjects and its immunogenicity against RSV.

Deep Belief Biotech was founded in 2019 and is committed to developing a world-leading LNP delivery technology platform and innovative RNA therapies to address unmet clinical needs.

Deeply Believing Biology Announces FDA Clinical Trial Approval for Bivalent RSV mRNA Vaccine on January 12, 2024IN006, a bivalent RSV mRNA vaccine independently developed by Deeply Believing Biology, has been granted clinical trial approval by the FDA. Utilizing a proprietary LNP delivery system and mRNA technology platform, as well as an independently designed and screened prefusion conformation F protein, IN006 has demonstrated robust protection in animal challenge models and shown good safety in preclinical studies.

In mid-June 2023, GSK's recombinant Respiratory Syncytial Virus (RSV) vaccine (AS01E adjuvant system) received the clinical trial implied permission from CDE, intended for the prevention of lower respiratory tract diseases in adults aged 60 years and above caused by RSV-A and RSV-B subtypes. In October, ZF Bio obtained the priority agency rights for this product in mainland China by signing the "Exclusive Distribution and Co-Promotion Agreement."

KangLe WeiShi is a biopharmaceutical company with structure-based antigen design as its core technology, mainly engaged in the research, development, and industrialization of recombinant protein vaccines.

According to information disclosed during Kangle Weishi's online roadshow for its listing on the Beijing Stock Exchange in March last year, the company's recombinant Respiratory Syncytial Virus (RSV) vaccine has obtained a stable cell line expressing the RSV vaccine antigen.Small-scale process research is currently underway, with preclinical studies and IND submission planned for 2023.。

Nuward Biopharma is a patient-centered, innovation-focused biopharmaceutical company founded in Shanghai in 2014 by Mr. Mark Lotter. Dedicated to addressing unmet critical healthcare needs in Greater China and the Asia-Pacific region, Nuward Biopharma boasts a differentiated global innovative drug pipeline and a mature portfolio of commercialized products, with a focus on therapeutic areas such as respiratory, pain management, emergency care, and iron deficiency anemia.

In March 2022, Nuance Pharmaceuticals entered into an exclusive agreement with Bavarian Nordic of Denmark to obtain the rights for the research, development, and commercialization of the MVA-BN RSV vaccine in Greater China (Mainland China, Hong Kong, Macao, and Taiwan regions), South Korea, and Southeast Asia.

Jiachen Xihai is a fastSpeedA clinical-stage biotechnology company focused on developing RNA-based biotherapeutics.Laws and vaccines, involving various RNA technology platforms such as traditional, self-replicating, and circular RNA. According to the company's official website, it has oneConventional mRNA RSV vaccine JCXH-108 is currently in the preclinical research stage., other detailed information has not been publicly disclosed.

Walvax Biotechnology was established in 2001 and listed on the ChiNext Board of the Shenzhen Stock Exchange in 2010. After more than 20 years of development, the company has become a modern high-tech biopharmaceutical enterprise in China that integrates the research, production, and sales of human vaccines and other biotechnological drugs. According to Walvax Biotechnology's 2022 annual report, during the reporting period, with the breakthroughs and development of new technologies, the advanced nature of the mRNA vaccine technology platform was validated in multiple mRNA vaccines.

On November 2, 2023, Walvax Biotechnology announced on an interactive platform that the company is currently exploring the development of innovative products such as the shingles mRNA vaccine and respiratory syncytial virus (RSV) mRNA vaccine based on its mRNA vaccine technology platform in collaboration with partners. These projects are currently in the preclinical research stage.

CSPC Holding Group Co., Ltd. is a national innovative enterprise that integrates the research, development, production, and sales of innovative drugs. According to the minutes of CSPC's 2022 earnings meeting, the company’s mRNA pipeline includes an RSV vaccine, for which an IND has been filed. CSPC's mRNA vaccine was the first in China to receive an EUA, and the company is also at the forefront internationally in LNP delivery technology.

Founded in 2011, Amoy Vaccines was listed on the Hong Kong Stock Exchange in 2022. It is the second-largest vaccine group in China and the largest private vaccine company, with business covering the entire industry value chain from research and development, manufacturing, to commercialization. It is the world's and China's largest hepatitis B vaccine manufacturer and the world's and China's second-largest rabies vaccine manufacturer. It has already reached 31 provinces, autonomous regions, and directly-administered municipalities in China.Municipal sales of vaccine products.

According to the R&D pipeline disclosed in AIM Vaccine's 2022 annual report, the company's mRNA Respiratory Syncytial Virus (RSV) vaccine is currently in the preclinical stage, with a CTA submission expected in the second quarter of 2024.

Wuhan Bohr Biotechnology Co., Ltd., established in 2012, is a "National High-tech Enterprise" specializing in the research, manufacturing, and marketing of high-end human vaccines. The company is committed to the development and industrialization of heavyweight products such as novel COVID-19 vaccines, multivalent human rotavirus vaccines, novel pneumococcal conjugate vaccines, broad-spectrum HPV vaccines, and recombinant herpes zoster vaccines.

According to the company's official website, its developed RSV vaccine isViral Vector Vaccine, using replication-defective type 5 adenovirus (Ad5) as a vector, with the F protein that induces RSV envelope fusion with host cells as the main target of the RSV vaccine, can avoid the "reversion to virulence" issue associated with live attenuated vaccines and the disease enhancement effect of inactivated vaccines. This product has currently enteredPilot Sample Preparation Phase。

ZhiFei Bio was established in 1995 and officially entered the biologics industry in 2002. It was listed on Shenzhen's Growth Enterprise Market (GEM) in 2010, becoming the first privately-owned vaccine company to be listed on the GEM. It has now developed into an international, full-industry-chain high-tech biopharmaceutical enterprise integrating the research and development, production, sales, promotion, distribution, and import and export of vaccines and biologics.

ZhiFei Bio has laid out in the RSV adult vaccine field, but there is not much related information. According to the company's 2022 annual report, itsRSV Vaccine Expected Progress (2023 to 2024): Preclinical Research Stage。

ZhiFei Biologics announced that its wholly-owned subsidiary, Beijing ZhiFei Green Bamboo Biopharmaceutical Co., Ltd., has recently filed for "a combination vaccine targeting Respiratory Syncytial Virus infection and its method of inducing immune response."Awarded the Invention Patent Certificate by the Intellectual Property Office of the Russian Federation. This invention patent was applied for during the collaboration between the company and Beijing Jiaotong University in developing a Respiratory Syncytial Virus (RSV) vaccine. The patent application date was August 11, 2021, and the patent term is 20 years from the application date. Currently, the product is still in the preclinical research stage.

Announcement of Zhifei Green Bamboo Obtaining International Patent Certificate (Source: Company Announcement)

Guangzhou SiAnSen Biotechnology Co., Ltd. is a high-tech growth enterprise founded by returning high-level talents. It mainly engages in the core business of vaccine carrier innovation technology and the research and development of new vaccines, technical consultation, and technology transfer. According to its official website, the company’s RSV candidate vaccine is a world-first creation with excellent protective effects, which can be administered via intramuscular injection or nasal drops, and is currently in the preclinical stage.

WestGene Biotech was founded in July 2021 by Professor Wei Yuquan, an academician of the Chinese Academy of Sciences and chief scientist of the Ministry of Science and Technology's "973" project, along with Professor Song Xiangrong, one of the first scientists in China to engage in mRNA technology research. It is a pharmaceutical technology company focusing on the development of innovative mRNA drugs and adjuvants. According to WestGene Biotech's official website, among the four pipelines in the company’s preventive vaccine R&D platform,A respiratory syncytial virus vaccine is currently in the early stage of drug development.。

Juntop Biotech, initiated by Shanghai Junshi Biosciences Co., Ltd., is an anti-infective vaccine/drug R&D platform company registered in Zhangjiang Science City in August 2021. Juntop Biotech has selected and laid out over 15 vaccine/drug pipeline projects in the anti-infective field, aiming to become a high-tech anti-infective vaccine/drug R&D and production entity with global reach, leading technology, and a rational product portfolio.

Ewei Pharmaceuticals was founded in 2021, with its headquarters located in Singapore and R&D centers in Boston and Shanghai. Ewei Pharmaceuticals is committed to introducing the world's leading core technologies in the mRNA field to meet the demand for mRNA COVID-19 vaccines and other high-end biopharmaceuticals in China and other regions.

In addition to its COVID-19 candidate vaccine, Everest Medicines is developing mRNA candidate vaccines for other infectious diseases, such as Respiratory Syncytial Virus (RSV) and Clostridioides difficile infection (CDI), continuously expanding its pipeline of follow-up products. It will provide more and advanced treatment options in the fields of infectious diseases, oncology, and autoimmune diseases.

Jiangsu Recbio Technology Co., Ltd. was founded in 2012 and is an innovative vaccine company driven by self-developed technology, committed to creating innovative vaccines that cover R&D, production, and commercialization.

September 2023,RecoBio has signed a Product Development Cooperation Agreement ("the Agreement") with Yikon Biotech (Suzhou) Co., Ltd. ("Yikon Biotech") to jointly develop a recombinant Respiratory Syncytial Virus (RSV) vaccine for the prevention of respiratory diseases caused by RSV.

Shenzhen Kangtai Biological Products Co., Ltd. was established in 1992, focusing on the research, production, and sales of human vaccines. It was listed on the ChiNext Board of the Shenzhen Stock Exchange in 2017, becoming the first vaccine company in South China to go public. The company owns more than 50 patents and has over 30 products in its research pipeline, covering nearly all major global vaccine varieties. According to the company’s 2022 annual report, it has initiated development of a recombinant Respiratory Syncytial Virus (RSV) vaccine, but did not disclose further details.

Maikang Bio was founded in 2016, focusing on the research, production, and sales of innovative vaccines and novel adjuvants. The company's founder and general manager is Dr. Chen Dexiang. Public information shows that Maikang Bio has established a pipeline containing more than ten innovative vaccines, two of which are in the clinical stage. It is expected that within the next year, 2 to 3 innovative vaccine products will receive IND approval.

The company's first-phase developments include a shingles vaccine for the elderly, a novel rotavirus vaccine, and a neonatal rotavirus vaccine. The product projects currently in planning encompass a multivalent pneumococcal conjugate vaccine, a hepatitis B therapeutic vaccine, and cancer treatment vaccines, among others.

Abogen Biosciences(Abogen) is an innovative biopharmaceutical company focused on the research and development of mRNA drugs, owning proprietary intellectual property rights for its mRNA and nanodelivery technology platforms. Relying on these technological platforms, the company has established a diverse product pipeline covering multiple fields, including the novel coronavirus.mRNA VaccineARCoV Granted Emergency Use Authorization in Indonesia; Its First mRNA Cancer Drug, ABO2011 Injection, Receives Clinical Approval from NMPA. Since the establishment of Abogen Biosciences in 2019, it has successfully completed Series A, B, C, and C+ financing rounds, supporting Abogen Biosciences' continued focus on innovative mRNA drug research and development.

Currently, Abogen Biosciences in the field of infectious diseases, in addition to the layout of COVID-19mRNAIn addition to vaccines, research on rabies is also ongoing,RSV, herpes zoster, etc.mRNAVaccine Development.

Changchun BCHT Biotechnology Co., Ltd. was established in 2004 as an innovative biopharmaceutical company primarily dedicated to the prevention and control of infectious diseases. The company is mainly engaged in the research, development, production, and sales of human vaccine products. Its parent company is Changchun High & New Technology Industries (Group) Inc. In June 2021, Baike Biotech successfully completed a spin-off listing, with Changchun High & New Technology Industries (Group) Inc. holding 41.54% of its shares.

According to the 2022 annual report of Baike Biotechnology, after nearly three years of exploration, the company has developed a nano-aluminum adjuvant, which has been used in the adsorbed acellular DTP (three-component) combination vaccine. It has currently completed Phase I clinical trials and is now in the verification and preparation stage for Phase III clinical samples.Nano-aluminum adjuvants will also be used in vaccines such as RSV.。

Guangdong South China Vaccine Co., Ltd., established in 2011, is an innovative R&D company specializing in recombinant protein nanoparticle vaccines. Relying on its own BEVS platform and team advantages, South China Vaccine has developed a variety of human, veterinary, and pet vaccine products, including a COVID-19 recombinant protein nanoparticle vaccine and an influenza recombinant protein nanoparticle vaccine.

According to its official website, South China Vaccine"Joint Innovation Vaccine Laboratory" Co-founded with the International Vaccine Centre of the Vaccine and Infectious Disease Organization at the University of Saskatchewan, Canada, and the Guangzhou Institute of Respiratory HealthThe three parties have reached a technical development agreement for the research and development of new respiratory syncytial virus and parainfluenza virus type 3 vaccines.